Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02888353 |
Recruitment Status :
Enrolling by invitation
First Posted : September 5, 2016
Last Update Posted : December 12, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary.
Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting.
This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Device:MRI | Device: Device: MRI | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3700 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | An Expanded Evaluation of the Safety of Clinically Indicated Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators |
Actual Study Start Date : | December 2015 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | February 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Device: MRI no pre-screen
Clinically Indicated MRI will be done in patients with cardiac devices (pacemakers and defibrillators). Patients will not be pre-screened prior to hospital visit. |
Device: Device: MRI
Perform MRI in patients with cardiac devices |
- acute patient safety and device malfunction [ Time Frame: 1 hour ]Number of participants with >30% change pre vs. post MRI in each of the following (pacing volts, sensing amplitude, battery life, and impedance (ohms), as a measure of safety
- chronic patient safety and device malfunction [ Time Frame: 1 to 6 weeks ]Number of participants with >30% change in each of the following (pacing volts, sensing amplitude, battery life, and impedance (ohms) 1 to 6 weeks post MRI as a measure of safety
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 9 Years to 100 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients implanted an ICD or pacemaker who have a clinical need for MR imaging
Exclusion Criteria:
- Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888353
United States, Maryland | |
Johns Hopkins Hospital, Zayed 5 MRI | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Henry R Halperin, MD/MA | Johns Hopkins University |
Publications of Results:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02888353 |
Other Study ID Numbers: |
IRB00068447 |
First Posted: | September 5, 2016 Key Record Dates |
Last Update Posted: | December 12, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Magnetic Resonance Imaging and Pacemakers ICD |